Medical tubing securement assembly and methods of use

ABSTRACT

A medical tubing securement assembly includes a base having a disc, and a retaining adapter removably and rotatably attached to the disc. The retaining adapter includes a longitudinal passage for receiving a locking adapter. The locking adapter includes a longitudinal passage for receiving a medical tube. Once the tube is inserted into the locking adapter, the locking adapter may be rotated within the retaining adapter, around the tube, to secure the tube within the securement assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/198,030, filed Aug. 4, 2011, entitled MEDICAL TUBING SECUREMENTASSEMBLY AND METHODS OF USE, now U.S. Pat. No. 8,177,756, which is acontinuation of U.S. patent application Ser. No. 11/532,194, filed Sep.15, 2006, now U.S. Pat. No. 8,052,649, entitled MEDICAL TUBINGSECUREMENT ASSEMBLY AND METHODS OF USE, which claims priority under 35U.S.C. §119(e) to U.S. Provisional Patent Application No. 60/718,619,filed Sep. 19, 2005, and U.S. Provisional Patent Application No.60/758,359, filed Jan. 12, 2006, each of which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The present invention relates in general to a device for securingmedical tubing, such as a Foley catheter, to a patient.

BACKGROUND

The use of medical tubing in various surgical and therapeutic treatmentsor during recovery is well known in the art. For example, urinarycatheters, CVCs, hemodialysis catheters, suprapubic catheters, surgicaldrainage tubes, feeding tubes, chest tubes, nasogastric tubes, scopes,as well as electrical wires or cables connected to external or implantedelectronic devices or sensors, are some of the various types of medicaltubing that are employed by medical practitioners. With respect tourinary catheters, some of the more common types include Foleycatheters, Coudé catheters, and Pezzer or mushroom catheters. Withrespect to urological procedures, catheterization often involvesinserting a tube (urinary catheter) through the urethra into the bladderto remove urine. The bladder is sterile, so surgical asepsis must beused when performing this procedure. A urinary catheter is generallyindicated when a person is unable to void naturally due to injury or adisease process, has had abdominal surgery, or is voiding overflow.

There are many different types of urinary catheters and each has aparticular purpose. A Coudé catheter has a tapered tip that is designedfor easy insertion when enlargement of the prostate is suspected. AFoley catheter has a balloon in its tip that is inflated after insertionso that it remains in the bladder. A Pezzer or Mushroom catheter has atriangular or knot-like tip and is used to drain urine from the renalpelvis; it can also be used for a suprapubic catheterization.

Simple urethral catheters are designed for in-and-out procedures. Athree-way indwelling catheter has a balloon in its tip that is inflatedafter it is inserted and also has another tube or lumen that can be usedfor continuous bladder irrigation. A suprapubic catheter is surgicallyinserted through the abdominal wall above the symphysis and into thebladder to divert urine from the urethra.

Foley catheters typically include a soft, thin rubber tube with aballoon on one end. The catheter is threaded through the urinary duct(urethra) and into the bladder to drain urine from the bladder. A Foleycatheter is typically used when normal urination is disrupted by aninfection, a swollen prostate gland, bladder stones, or, sometimes, aninjury. In very sick people, a catheter may be used to keep track ofurine production.

A typical Foley catheter has a drainage lumen and an inflation lumen forinflating and deflating the balloon. The balloon is normally deflateduntil properly positioned in a patient's bladder by inserting thecatheter through the urinary tract of the patient and advancing thecatheter until the tip of the catheter reaches the patient's bladder.Although the catheter usually includes a siliconized outer coating, asprovided by the manufacturer, healthcare providers often apply furtherlubricant, such as a water-based jelly. Once the catheter is properlypositioned, the inflation lumen delivers fluid (e.g., saline solution)to inflate the balloon. Once-inflated, a valve, which is located at theinflation port, inhibits the flow of fluid from the inflation lumen andthe balloon to keep the balloon inflated. The inflated balloon preventsthe catheter from unintentionally dislodging from the bladder. Thehealthcare provider then connects the distal end of the drainage lumen(i.e., its effluent port) to a drainage tube leading to a collectioncontainer.

Once a Foley catheter, or other tubing, is inserted into, the patient,the part of the tubing that is on the outside of the patient(extracorporeal tubing) is typically secured to the patient's body usingmedical tape. This is done to reduce the risk of accidentally pulling ordislodging the tubing by inadvertently wrapping it around a limb orbedrail or knocking it out of position. With respect to Foley catheters,the healthcare provider commonly places long pieces of tape across thedistal end of the catheter in a crisscross pattern to secure thecatheter distal end to the inner thigh of the patient.

Medical tape has proven to be an unsatisfactory and crude means ofsecuring medical tubing to a patient. One problem is that medical tapecan crush the tubing and impede fluid flow. Another problem is thatmedical tape does not provide any freedom of movement to the tubing withrespect to the patient's body. Consequently, any movement in the tubingcaused by the patient's movements may cause the tape to twist and peelaway from the skin and to generally fail. Yet another problem is thatmedical tape often collects contaminants and dirt. Standard protocoltherefore typically requires periodic tape changes in order to inhibitbacteria and germ growth at the securement site.

Frequent tape changes may, however, lead to another problem: excoriationof the patient's skin. In addition, valuable healthcare provider time isspent applying and reapplying the tape to secure the catheter. Andhealthcare providers often remove their gloves when taping because mostfind the taping procedure difficult and cumbersome when wearing gloves.Not only does this further lengthen the procedure, but it also subjectsthe healthcare provider to possible infection.

Thus, it is highly desirable to have a new and improved device andmethod for securing medical tubing to a patient that overcomes theproblems associated with medical tape.

SUMMARY

A medical tubing securement assembly includes a base having a disc, anda retaining adapter removably and rotatably attached to the disc. Theretaining adapter includes a longitudinal passage for receiving alocking adapter. The locking adapter includes a longitudinal passage forreceiving a medical tube. Once the tube is inserted into the lockingadapter, the locking adapter may be rotated within the retainingadapter, around the tube, to secure the tube within the securementassembly.

Other features and advantages of the invention will appear hereinafter.The features of the invention described above can be used separately ortogether, or in various combinations of one or more of them. Theinvention resides as well in sub-combinations of the features described.Furthermore, many of the method steps described herein may be performedin a different order than that which is explicitly described.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, wherein the same reference number indicates the sameelement throughout the several views:

FIG. 1 is a perspective view of a medical tubing securement assemblysecuring a Foley catheter.

FIG. 2 is a perspective view of the medical tubing securement assemblydepicted in FIG. 1 with the base pad and the Foley catheter removed.

FIG. 3 is a perspective view of the base plate depicted in FIGS. 1 and2.

FIGS. 4A and 5A are alternate perspective views of the retaining adapterof the medical tubing securement assembly depicted in FIG. 1.

FIGS. 4B and 5B are alternate perspective views of the locking adapterof the medical tubing securement assembly depicted in FIG. 1.

DETAILED DESCRIPTION

Various embodiments of the invention will now be described. Thefollowing description provides specific details for a thoroughunderstanding and enabling description of these embodiments. One skilledin the art will understand, however, that the invention may be practicedwithout many of these details. Additionally, some well-known structuresor functions may not be shown or described in detail so as to avoidunnecessarily obscuring the relevant description of the variousembodiments.

The terminology used in the description presented below is intended tobe interpreted in its broadest reasonable manner, even though it isbeing used in conjunction with a detailed description of certainspecific embodiments of the invention. Certain terms may even beemphasized below; however, any terminology intended to be interpreted inany restricted manner will be overtly and specifically defined as suchin this detailed description section.

Where the context permits, singular or plural terms may also include theplural or singular term, respectively. Moreover, unless the word “or” isexpressly limited to mean only a single item exclusive from the otheritems in a list of two or more items, then the use of “or” in such alist is to be interpreted as including (a) any single item in the list,(b) all of the items in the list, or (c) any combination of items in thelist.

For ease of description, the present embodiments of the medical tubingsecurement assembly will be described in the context of securing anexemplary Foley catheter. The principles of the present invention,however, are not limited to Foley catheters. Indeed, it will beunderstood by one of skill in the art, in view of the presentdisclosure, that the medical tubing securement assembly disclosed hereincan also be used to secure other types of medical tubing, includingtubes for fluid communication and electrical wires.

The medical tubing securement assemblies disclosed herein may be adaptedto retain other types of urinary catheters, including, but not limitedto, CVCs, hemodialysis catheters, suprapubic catheters, surgicaldrainage tubes, feeding tubes, chest tubes, nasogastric tubes, scopes,as well as electrical wires or cables connected to external or implantedelectronic devices or sensors. One skilled in the art may also findadditional applications for the devices disclosed herein. Thus, theillustrations and descriptions of securement assemblies disclosed hereinin connection with a Foley catheter are merely exemplary of one possibleapplication of the device.

Referring now to the drawings, FIG. 1 illustrates a medical tubingsecurement assembly 10 in which an exemplary Foley catheter 400 issecured. The Foley catheter 400 includes a primary tube 405 and asecondary tube or inflation lumen 410. The medical tubing securementassembly 10 secures the Foley catheter 400 firmly in place against apatient's skin, via a base pad 100. In the case of the Foley catheter400, the base pad 100 may be secured to the patient's thigh.

As illustrated in FIGS. 1 and 2, the securement assembly 10 includes thebase pad 100, a base plate 200, a retaining adapter 300, and a lockingadapter 370 or catheter fitting mount. The retaining adapter 300 ispreferably rotatable about a disc 220 on the base plate 200.Alternatively, the retaining adapter 300 may be fixedly secured to thedisc 220, and the disc 220 may be rotatable about the base plate 200.Removable wax backing strips (not shown) are optionally included on abottom surface of the base pad 100.

In one embodiment, the top surface of the base pad 100 may be secured tothe bottom surface of the base plate 200 with a non-skin irritatingadhesive. The bottom surface of the base plate 200 or the top surface ofthe base pad 100 may be coated with the non-skin irritating adhesive.The securement assembly 10 may then be secured to the patient's skin byremoving the wax paper strips and adhering the bottom surface of thebase pad 100 to the skin, or in any other suitable manner.

In another embodiment, as shown in FIG. 1, the bottom surface of thebase pad 100 may be secured to the top surface of the base plate 200,along the edges of the base plate 200, with a non-skin irritatingadhesive. The non-skin irritating adhesive may be coated on the bottomsurface of the base pad 100 or on the edges of the top surface of thebase plate 200. The base pad 100 can therefore sandwich the base plate200 between the bottom surface of the base pad 100 and the patient'sskin. In addition, the bottom surface of the base plate 200 can becoated with a non-skin irritating adhesive, and both the bottom surfaceof the base pad 100 and the bottom surface of the base plate 200 can beadhered to the skin of the patient.

Alternatively, the base plate 200 can be sandwiched between the base pad100 and a layer of double-sided medical tape secured to the bottomsurface of the base plate 200. The double-sided medical tape may becoated with a non-skin irritating adhesive to secure the top surface ofthe tape to the bottom surface of the base plate 200, and the bottomsurface of the tape to the patient's skin.

Turning to FIG. 3, in one embodiment, the base plate 200 includes aplatform 210 with a substantially flat top surface and a substantiallyflat bottom surface. The edges 212 of the platform 210 may optionally besloped. The platform 210 may be shaped as a square, a rectangle, acircle, an oval, or may have any other suitable configuration. Forexample, the platform may include two opposing arms extending in adistal direction toward the patient's site of incision or catheterinsertion, as opposed to having a uniform square shape, as described inU.S. Provisional Application Ser. No. 60/718,619 filed, Sep. 19, 2005,which is incorporated herein by reference.

The platform 210 optionally includes a central opening 215 over which abridge 230 extends. The disc 220 rests atop the bridge 230. One or moreraised pedestals (not shown) may optionally be included atop theplatform to provide additional support to the retaining adapter 300 asit rotates atop the disc 220. The disc 220 may have any suitablediameter, preferably between 0.5 cm to 5.0 cm. In one embodiment, thedisc has a diameter of approximately 1.8 cm. The disc 220 preferably hasa substantially flat top surface and includes a protuberance 224 at itscenter, which forms a spindle. The protuberance 224 may be cone-shaped,round or hemispherical, bell-shaped, or have any other suitableconfiguration. A raised ring 226 optionally forms a lip or snap-ring atan outer rim of the disc 220. The retaining adapter 300 preferably snapsor otherwise fits onto the lip formed by the raised ring 226, asdescribed below.

The platform 210, bridge 230, disc 220, protuberance 224, and ring 226of the base plate 200 may optionally be a unibody construction made froma single mold. Alternatively, one or more of these components may beformed from one or more separate molds and connected to the othercomponents via adhesive, welding, or via any other suitable manner. Eachof the components of the medical securement assembly 10 may be made ofany suitable material, such as a flexible plastic or elastomericmaterial.

Turning to FIGS. 4A and 5A, the retaining adapter 300 includes aproximal sleeve 320 forming an upper opening 321, a distal sleeve 310forming a lateral opening 319, and a bridge 360 connecting the two. (Asused herein, the proximal direction is from the center of the securementassembly 10 toward the proximal sleeve 320, and the distal direction isfrom the center of the securement assembly 10 toward the distal sleeve310.) The upper opening 321 is preferably not in longitudinal alignmentwith the lateral opening 319. The upper opening 321 is preferablyshifted by 1° to 120°, or 45° to 100°, or 60° to 90°, with respect tothe lateral opening 319. In one embodiment, the upper opening 321 isshifted approximately 90° with respect to the lateral opening 319.

The distal edge of the distal sleeve 310 optionally forms asubstantially backwards “C” shape. The distal edge preferably includes arecessed section 318 defined between a first raised section 312 and asecond raised section 313. A protuberance or projection 314 preferablyresides within the recessed section 318 for securing the locking adapter370 into the locked position, as described below. The proximal sleeve320 optionally includes a recessed section 350 or indentation on aninner surface thereof for accommodating a raised wedge 550 or elevatedsegment on the locking adapter 370, as described below.

The distal sleeve 310 may include one or more directional markers, suchas an arrow 315 and a lock indicator 317. The arrow 315 preferablypoints in the distal direction toward the intended site of incision orinsertion of the catheter. The lock indicator 317 indicates the positionto which a lever 540 on the locking adapter 370 should be rotated tosecure the Foley catheter 400 within the securement assembly 10, asdescribed below. The distal sleeve 310 also preferably includes aretainer tab 316 that extends from the top side of the distal sleeve 310toward the proximal sleeve 320. The distal sleeve 310 and the proximalsleeve 320 are preferably connected at their bottom portions via thebridge 360, leaving the remainder of the sleeves 310 and 320 disjoined.

Accordingly, a gap exists between the proximal sleeve 320 and the distalsleeve 310 that extends substantially perpendicularly to thelongitudinal axis of the retaining adapter 300. The gap can accommodate,and provides a passageway for, a side branch of a medical tube, such asthe inflation lumen 410 of the Foley catheter 400. The gap, inconjunction with the lateral opening 319, also provides an opening intowhich the Foley catheter may be inserted, as described below.

In one embodiment, the retaining adapter 300 is secured or attached tothe base plate 200 in a manner allowing it to rotate or spin atop thedisc 220. The retaining adapter 300 includes a front or distal support330 with a first connection groove 331, and a rear or proximal support335 with a second connection groove 332. The raised ring 226 on the disc220 may be inserted into the first and second connection grooves 331 and332 to provide a track on which the distal and proximal supports 330 and335 slide or run. This connection between the retaining adapter 300 andthe disc 220 allows the adapter 300 to rotate atop the disc 220.Alternatively, the retaining adapter 300 may be fixedly secured to thedisc 220, and the disc 220 may be rotatable about the bridge 230 or theplatform 210 of the base plate 200.

The retaining adapter 300 preferably includes a cavity or opening (notshown) on its bottom surface, approximately midway between the distalsupport 330 and the proximal support 335. The cavity mates with theprotuberance 224 on the disc 220. The bottom surface of the retainingadapter 300 is preferably spaced apart from the top surface of the disc220. The gap provided by this spacing reduces friction between theretaining adapter 300 and the disc 220 when the retaining adapter 300 isrotated, allowing for freer rotation of the retaining adapter 300 atopthe disc 220.

The retaining adapter 300 is secured to the disc 220 via insertion ofthe raised ring 226 into the first and second connection grooves 331 and332. Although the retaining adapter 300 is preferably removable, itcannot be removed from the disc 220 simply by pulling the retainingadapter 300 in an upward manner; the groove/ring connection prohibitssuch detachment. The retaining adapter 300, however, is preferably madeof a flexible material that allows the bridge 360 of the retainingadapter 300 to flex or bend.

When the proximal and distal sleeves 320 and 310 of the retainingadapter 300 are squeezed toward each other, the bridge 360 flexes suchthat the proximal and distal sleeves 320 and 310 tilt inwardly towardeach other, and the proximal and distal supports 335 and 330 are forcedupward and away from each other. This upward and outward movement of theproximal and distal supports 335 and 330 frees the ring 226 from theproximal and distal connection grooves 332 and 331, consequently freeingthe retaining adapter 300 from the disc 220. Thus, the retaining adapter300 can be detached from the disc 220 by squeezing the proximal anddistal sleeves 320 and 310 toward each other. The adapter 300 can bereattached to the disc 220 by positioning one of the connection grooves331 and 332 over the ring 226 and snapping or otherwise forcing theother connection groove over the ring 226. The bend able bridge 360returns to its original substantially level state unless a force causesit to bend out of its level state.

In one embodiment, as shown in FIGS. 1-3, the disc 220 is orientedhorizontally or parallel to the platform 210 of the base plate 200. Inanother embodiment (not shown), the disc 220 is attached at an angle inrelation to the platform 210. For example, the disc 220 may be at anangle of approximately 1° to 30° in relation to the platform 210. In oneembodiment, the disc 220 is at an angle of approximately 5°, or 10°, or15°, or 20°, or 25°, or 30°, in relation to the platform 210. This angleof inclination may be accomplished by raising one side of the bridge 230relative to the other side of the bridge 230. A side of the bridge 230can be raised by adding a step underneath that side of the bridge 230,or by making one side of the bridge 230 thicker than the other side, orin any other suitable manner. This angled configuration may be used toprovide, for example, an angle of inclination for directing the medicaltubing toward the patient's skin.

Turning to FIGS. 48 and 58, the locking adapter 370 includes a proximalsleeve 520 forming a first opening 521, a distal sleeve 510 forming asecond opening 519, and a substantially arcuate or semi-circular bridge560 connecting the two. The distal sleeve 510 includes a lever 540 orhandle for facilitating manual rotation of the locking adapter 370, whenthe locking adapter 370 is positioned within the retaining adapter 300,as described below.

The proximal sleeve 520 optionally includes a wedge 550 or otherelevated segment on an outer surface thereof for providing aninterference fit with an inner surface of the proximal sleeve 320 of theretaining adapter 300 (as is best shown in FIG. 2). The wedge 550 ispreferably dimensioned to fit within the recessed section 350 in theinner surface of the proximal sleeve 320 of the retaining adapter 300when the locking adapter 370 is in an unlocked position, such thatlittle or no interference fit occurs in the unlocked position.

The proximal sleeve 520 further preferably includes a raised outer rim570 or edge that abuts a proximally outer surface of the proximal sleeve320, as shown in FIG. 2, to substantially limit or prevent distalmovement of the locking adapter 370 within the retaining adapter 300.The outer dimensions of the distal and proximal sleeves 510 and 520 ofthe locking adapter 370 are preferably substantially complementary withthe inner dimensions of the distal and proximal sleeves 310 and 320 ofthe retaining adapter 300 so that the locking adapter 370 fits closelywithin, and is rotatable within, the retaining adapter 300, as describedbelow.

The opening 519 in the distal sleeve 510 is preferably wide enough toaccommodate a medical tube, such as the Foley catheter 40, when the tubeis squeezed through the opening 519 and into the space or tunnel formedby the inner surface of the distal sleeve 510. Alternatively, theopening 519 may be narrower than the medical tube, as long as thelocking adapter 370 (and the retaining adapter 300) is made of amaterial flexible enough to allow the opening 519 to be enlarged bypushing the free opposing surfaces of the distal sleeve 510 away fromeach other to allow the medical tube to be squeezed through the opening519. Once the medical tube is squeezed through the opening 519 thedistal sleeve 510 returns to its original shape.

Similarly, the opening 521 in the proximal sleeve 520 is preferably wideenough that a medical tube, such as the Foley catheter 400, can besqueezed through the opening 521 and into the space or tunnel formed bythe inner surface of the proximal sleeve 520. Alternatively, the opening521 may be narrower than the medical tube, as long as the lockingadapter 370 (and the retaining adapter 300) is made of a material thatis flexible enough to allow the opening 521 to be enlarged by pushingthe free opposing surfaces of the proximal sleeve 520 away from eachother to allow the medical tube to be squeezed through the opening 521.Once the medical tube is squeezed through the opening 521 the proximalsleeve 520 returns to its original shape.

As illustrated in FIGS. 1 and 2, the locking adapter 370 fits closelywithin the retaining adapter 300 while still being free to rotatetherein. The locking adapter 370 may be inserted into the retainingadapter 300 by sliding it in the distal direction through the opening inthe proximal end of the proximal sleeve 320 with the lever 540 orientedin a substantially upward direction. When (or slightly before) the lever540 comes into contact with the retainer tab 316 on the distal sleeve310 the locking adapter 370 may be rotated (in a counterclockwisedirection in FIGS. 1 and 2) until the lever 540 is aligned with thelateral opening 319 in the distal sleeve 310.

The locking adapter 370 may then be moved in the distal direction untilthe raised outer rim 570 abuts against the proximally outer surface ofthe proximal sleeve 320, which prevents the locking adapter 370 fromfurther distal movement. The lever 540 may then be manually pulled orforced distally beyond the first raised section 312 and rotated(clockwise in FIGS. 1 and 2) across the first raised section 312 untilthe lever 540 flexes back into its original form and resides in therecessed section 318 of the distal sleeve 310. The lever 540 ispreferably made of a material flexible enough to slightly bend or flex,in response to a force applied in the distal direction, so that it maypass over the first raised section 312 and then return to its originalform.

In this open or unlocked position, a side edge of the lever 540 abuts aninner edge of the first raised section 312, such that the lever 540 isoriented in a substantially upward manner. In this position, the firstopening 521 in the locking adapter 370 is substantially or perfectlyaligned with the upper opening 321 in the retaining adapter 300, and thesecond opening 519 in the locking adapter 370 is substantially orperfectly aligned with the lateral opening 319 in the retaining adapter300. The first opening 521 and the upper opening 321 preferably havesubstantially the same dimensions, as do the second opening 519 and thelateral opening 319. Accordingly, when the openings are aligned in theunlocked position, a medical tube, such as the Foley catheter 400, maybe inserted through both layers of openings for securement within thesecurement assembly 10.

To insert the Foley catheter 400 into the securement assembly 10 in theunlocked position, a mid-region or other region of the primary tube 405is inserted through the lateral opening 319 of the retaining adapter 300and the corresponding second opening 519 of the locking adapter 370 (andthrough the neighboring lateral gap). The proximal end of the primarytube 405 is inserted through the upper opening 321 in the retainingadapter 300 and the corresponding first opening 521 in the lockingadapter 370. In this position, the primary tube 405 passes through, andis reasonably secured within, the distal sleeve 510 and the proximalsleeve 520 of the locking adapter 370.

If the inflation lumen or tube 410 is not already aligned with the lockindicator 317, the inflation tube 410 is rotated (clockwise in FIGS. 1and 2) until it protrudes through the opening between the proximalsleeves 320 and 520 and distal sleeves 310 and 510 aligned with the lockindicator 317, as shown in FIG. 1. At this point, the Foley catheter 400is in its working position.

Once the Foley catheter 400 is in the working position, the lockingadapter 370 is rotated (clockwise in FIGS. 1 and 2), via the lever 540,around the medical tube until the lever 540 passes over the projection314 in the recessed section 318 and abuts the second raised section 313on the distal sleeve 310. As a result, the Foley catheter 400 is heldsecurely within the securement assembly 10 so that it is prevented frompulling out of the securement assembly 10, as described below.

FIGS. 1 and 2 show the securement assembly 10 in the locked position.The projection 314 assists in holding the lever 540 in the lockedposition. The lever 540 is preferably made of a material flexible enoughto slightly bend or flex, in response to a force applied in the distaldirection, so that it may pass over the projection 314 and then returnto its original form. If included, the wedge 550 on the proximal sleeve520 of the locking adapter 370 slides underneath the proximal sleeve 320of the retaining adapter 300 such that an upper surface of the wedge 550engages in an interference fit with an inner surface of the proximalsleeve 320 to further secure the locking adapter 370 in the lockedposition.

In the locked position, portions of the distal sleeve 510 and the bridge560 of the locking adapter 370 block the lateral opening 319 and theneighboring lateral gap in the retaining adapter 300 so the Foleycatheter 400 cannot slide laterally out of the securement assembly 10.Similarly, the portion of the proximal sleeve 520 of the locking adapter370 including the wedge 550 blocks the upper opening 321 in the proximalsleeve 320 of the retaining adapter 370 so the Foley catheter 400 cannotslide out of the upper opening 321. As a result, the Foley catheter 400(or other medical tube) is securely held within the securement assembly10 when the securement assembly 10 is in the locked position.

To remove the Foley catheter 400 from the securement assembly 10, thelever 540 is rotated (counterclockwise in FIGS. 1 and 2) until it abutsthe first raised section 312 on the distal sleeve 310. In this position,the first and second openings 521 and 519 in the locking adapter 370 arealigned with the upper and lateral openings 321 and 319, respectively,in the proximal sleeve 320. As a result, the Foley catheter 400 mayreadily be removed from the securement assembly 10 by pulling it outthrough the aligned openings.

The medical tubing securement assembly 10 may be, packaged as a kitincluding the base pad 100, the base plate 200 (including the disc 220),the retaining adapter 300, the locking adapter 370, and instructions foruse. In one embodiment, a separate disc may also be included in a kitthat includes a variable angle medical tubing securement assembly, asdescribed in U.S. Provisional Application Ser. No. 60/718,619. The kitmay be contained in a hermetically sealed package that includes writteninstructions on the package, inside the package, or separate from thepackage.

The instructions provide a method for using the medical tubingsecurement assembly 10. First, the medical tubing, such as a Foleycatheter, is introduced into the patient's body. A skin preparationsolution can then be applied for enhanced adherence and skin protection,after which the base pad 100 is adhered to the patient's skin. Themethod described above for inserting the medical tubing into thesecurement assembly 10 is then performed. The retaining adapter 300 maybe attached to the disc 220 on the base plate 200 before or after themedical tubing is secured in the securement assembly 10.

Specific details and examples of variable angle assemblies, base plates,discs, and so forth are described in U.S. Provisional Application Ser.No. 60/718,619. While specific embodiments of a securement assembly 10have been described herein, any securement assembly in which one or moreopenings in a retaining adapter and a locking adapter are alignable withone another in an unlocked position, and in which one or both of theadapters are rotatable into a locked position wherein one or more of theopenings are blocked, is contemplated by the present invention.

Thus, while several embodiments have been shown and described, variouschanges and substitutions may of course be made, without departing fromthe spirit and scope of the invention. The invention, therefore, shouldnot be limited, except by any claims and their equivalents.

What is claimed is:
 1. A method for securing a medical article to apatient, the medical article including a primary tube and a secondarytube, comprising: providing a locking adapter rotatably disposed withina retaining adapter, the locking adapter having a first opening and asecond opening, the retaining adapter having an upper opening and alateral opening; inserting a first portion of the primary tube throughthe lateral opening and the second opening; inserting a second portionof the primary tube through the upper opening and the first opening;positioning the secondary tube so that the secondary tube extendsthrough the upper opening and the first opening; and rotating thelocking adapter relative to the retaining adapter to a locked position.2. The method as in claim 1, wherein the locking adapter defines achannel having a central axis, and wherein at least a portion of thelocking adapter is rotated about the central axis when the lockingadapter is moved to the locked position.
 3. The method as in claim 1,wherein the second portion of the primary tube is inserted through theupper opening and the first opening before the first portion of theprimary tube is inserted through the lateral opening and the secondopening.
 4. The method as in claim 1 further comprising: providing abase plate; and engaging the retaining adapter with the base plate. 5.The method as in claim 4 wherein engaging the retaining adapter with thebase plate comprises sliding the retaining adapter relative to the baseplate.
 6. The method as in claim 4 further comprising: bending theretaining adapter into a bent configuration; and disengaging theretaining adapter from the base plate when the retaining adapter is inthe bent configuration.
 7. The method as in claim 4 further comprising:providing a base pad, the base plate being secured relative to the basepad; and adhering the base pad to the skin of a patient.
 8. The methodas in claim 4 further comprising rotating the retaining adapter relativeto the base plate.
 9. The method as in claim 8 further comprisingrotating the locking adapter relative to the base plate, wherein theretaining adapter rotates relative to the base plate about a first axisand the locking adapter rotates relative to the base plate about asecond axis, the second axis being different than the first axis. 10.The method as in claim 9 wherein the first axis is not parallel to thesecond axis.
 11. The method of claim 1 further comprising actuating alever on the locking adapter when rotating the locking adapter relativeto the retaining adapter, the lever extending through the retainingadapter at least when the locking adapter is in the locked position. 12.A method for securing a medical article to a patient, the medicalarticle including a first tube and a second tube, the second tubeintersecting the first tube, comprising: providing a locking adaptersecured within a retaining adapter, the locking adapter having a firstopening and a second opening, the retaining adapter having a centralaxis, a third opening, and a fourth opening; inserting one of the firstand second tubes through the fourth opening and the second opening;inserting one of the first and second tubes through the third openingand the first opening; positioning one of first and second tubes toextend through the third opening and the first opening; and rotating thelocking adapter about the central axis of the retaining adapter.
 13. Themethod of claim 12, wherein the first opening is disposed in a firstproximal sleeve, and wherein the second opening is disposed in a firstdistal sleeve, the first proximal sleeve defining at least a portion ofthe locking adapter and being connect to the first distal sleeve by abridge.
 14. The method of claim 12, wherein the fourth opening is notlongitudinally aligned with the third opening.
 15. The method of claim12, wherein the fourth opening is oriented approximately 90° relative tothe third opening.
 16. The method of claim 12, wherein the third openingis disposed in a first proximal sleeve, and wherein the fourth openingis disposed in a first distal sleeve, the first proximal sleeve definingat least a portion of the retaining adapter and being connect to thefirst distal sleeve by a bridge.
 17. A method for securing a medicaltube to a patient, comprising: providing a locking adapter rotatablewithin a retaining adapter; inserting a medical tube through alignedopenings in the retaining adapter and the locking adapter; and rotatingthe locking adapter relative to the retaining adapter to move theopening in the locking adapter out of alignment with the opening in theretaining adapter.
 18. The method of claim 17 further comprisingsecuring the retaining adapter relative to the patient.
 19. The methodas in claim 17, wherein the locking adapter defines a channel having acentral axis, and wherein at least a portion of the locking adapter isrotatable about the central axis.
 20. The method as in claim 17 furthercomprising engaging an elevated wedge on an outer surface of the lockingadapter with an inner surface of the retaining adapter when the openingin the locking adapter is out of alignment with the opening in theretaining adapter.